Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0809-2020 — Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

U.S. FDA — Device Enforcement · Israel · 2019-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0809-2020
Date of alert
2019-12-02
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Degania Silicone, Ltd.
Product category
device
Product type
Devices
Reported risk: Temperature deviation did not meet release specifications
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.